Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 weeks in patients with primary immunoglobulin A nephropathy.

The FDA has granted accelerated approval to Novartis’ Vanrafia for adults with primary immunoglobulin A nephropathy (IgAN).

Novartis has positioned Vanrafia as a “foundational therapy” in IgAN because it can address a broad population of patients with persistent proteinuria, the company’s U.S. president, Victor ...

Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...

Novartis is uniquely positioned to lead a transformation in kidney care Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring ...

Novartis (NVS) “announced the FDA has granted accelerated approval for Vanrafia, or atrasentan, a potent and selective endothelin A receptor ...

FDA grants accelerated approval to Novartis' Vanrafia for IgA nephropathy, with Phase 3 data in 2026 expected to support ...

Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US for IgAN, a disease characterised by the accumulation of antibodies in the ...

Novartis has received accelerated approval from the US Food and Drug Administration (FDA) for Vanrafia (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, ...

Novartis is uniquely positioned to lead a transformation in kidney care Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring ...